High Risk Myelodysplastic Syndrome Clinical Trial
Official title:
Phase 2 Study of SGI-110 in Patients With Higher Risk MDS
This phase II trial studies how well guadecitabine works in treating patients with myelodysplastic syndromes that are at higher risk for becoming acute myeloid leukemia. Guadecitabine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES: I. To evaluate the complete response (CR) rate with SGI-110 (guadecitabine) in patients with higher risk myelodysplastic syndrome (MDS). SECONDARY OBJECTIVES: I. Overall response rate, survival, transformation to acute myeloid leukemia (AML), transfusion independence. II. Safety and toxicity. OUTLINE: Patients receive guadecitabine subcutaneously (SC) on days 1-5. Treatment repeats every 4-8 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity. Patients with stable disease after 3 courses are taken off therapy after 6 courses. Patients may continue to receive treatment after 24 courses if the investigator determines it is in the patient's best interest. After completion of study treatment, patients are followed up at 30 days, and then every 2 months. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03214562 -
Venetoclax With Combination Chemotherapy in Treating Patients With Newly Diagnosed or Relapsed or Refractory Acute Myeloid Leukemia
|
Phase 1/Phase 2 | |
| Recruiting |
NCT03589729 -
Dexrazoxane Hydrochloride in Preventing Heart-Related Side Effects of Chemotherapy in Participants With Blood Cancers
|
Phase 2 | |
| Terminated |
NCT03067571 -
Daratumumab in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
|
Phase 2 | |
| Completed |
NCT03263637 -
Study to Assess Safety, Tolerability, Pharmacokinetics and Antitumor Activity of AZD4573 in Relapsed/Refractory Haematological Malignancies
|
Phase 1 | |
| Recruiting |
NCT04047641 -
Cladribine, Idarubicin, Cytarabine, and Quizartinib in Treating Patients With Newly Diagnosed, Relapsed, or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
|
Phase 1/Phase 2 | |
| Recruiting |
NCT03630991 -
Edetate Calcium Disodium or Succimer in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome Undergoing Chemotherapy
|
Phase 1 | |
| Recruiting |
NCT03672539 -
Liposome-encapsulated Daunorubicin-Cytarabine and Gemtuzumab Ozogamicin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) or High Risk Myelodysplastic Syndrome
|
Phase 2 | |
| Active, not recruiting |
NCT03094637 -
Azacitidine and Pembrolizumab in Treating Patients With Myelodysplastic Syndrome
|
Phase 2 | |
| Terminated |
NCT01636609 -
Tosedostat and Cytarabine or Azacitidine in Treating Older Participants With Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome
|
Phase 1 | |
| Completed |
NCT03047993 -
Glutaminase Inhibitor CB-839 and Azacitidine in Treating Patients With Advanced Myelodysplastic Syndrome
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04128748 -
Liposomal Cytarabine and Daunorubicin (CPX-351) and Quizartinib for the Treatment of Acute Myeloid Leukemia and High Risk Myelodysplastic Syndrome
|
Phase 1/Phase 2 | |
| Completed |
NCT03358719 -
DEC-205/NY-ESO-1 Fusion Protein CDX-1401, Poly ICLC, Decitabine, and Nivolumab in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia
|
Phase 1 | |
| Completed |
NCT01823198 -
Donor Natural Killer Cells and Donor Stem Cell Transplant in Treating Patients With High Risk Myeloid Malignancies
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT02530034 -
Hu8F4 in Treating Patients With Advanced Hematologic Malignancies
|
Phase 1 | |
| Recruiting |
NCT04262843 -
Total Marrow and Lymphoid Irradiation as Conditioning Regimen Before Hematopoietic Cell Transplantation in Patients With Myelodysplastic Syndrome or Acute Leukemia
|
Phase 2 | |
| Completed |
NCT02029950 -
Pomalidomide After Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
|
Phase 1 | |
| Active, not recruiting |
NCT02861417 -
Busulfan, Fludarabine Phosphate, and Post-Transplant Cyclophosphamide in Treating Patients With Blood Cancer Undergoing Donor Stem Cell Transplant
|
Phase 2 | |
| Recruiting |
NCT00801489 -
Fludarabine Phosphate, Cytarabine, Filgrastim-sndz, Gemtuzumab Ozogamicin, and Idarubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
|
Phase 2 | |
| Completed |
NCT01236144 -
A Trial to Establish the Feasibility of Combining Either the Tyrosine Kinase Inhibitor AC220,CXCR4 Inhibitor Plerixafor or HSP90 Inhibitor Ganetespib With Chemotherapy in Older Patients With Acute Myeloid Leukaemia and High Risk Myelodysplastic Syndrome.
|
Phase 1/Phase 2 |